Effects of Menstrual Cycle Phases on Gait, Pelvis, and Sleep

NCT07152262 | Recruiting

• 1 other identifier: Menstrual Cycle
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effects of different phases of the menstrual cycle on gait spatiotemporal characteristics, pelvic kinematics, and sleep quality in healthy women aged 18-35 years with regular menstrual cycles. Participants will be assessed in three phases of the cycle: early follicular (days 1-3), ovulation (days 7-9, confirmed by ovulation test), and luteal (days 20-23). Gait parameters and pelvic kinematics will be evaluated using the BTS-G walk sensor system, while sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). The study seeks to determine whether physiological and hormonal changes during menstrual phases lead to measurable differences in gait, pelvic motion, and sleep quality.

Conditions

Menstrual Cycle; Sleep; Gait

Outcome Measures

Primary Outcomes (6)

• Change in Gait Speed Across Menstrual Phases

  Within-subject change in comfortable gait speed (meters/second (m/s)) measured by BTS-G walk sensor in three phases: early follicular (days 1-3), ovulation (days 7-9; salivary test-confirmed), luteal (days 20-23).

  Within one menstrual cycle (~3-4 weeks).

• Change in Cadence Across Menstrual Phases

  Within-subject change in step cadence( steps/min) recorded by BTS-G walk across the same three phases.

  Within one menstrual cycle (~3-4 weeks).

• Change in Stride Length Across Menstrual Phases

  Within-subject change in stride length (centimeters/cm) captured by BTS-G walk across the three phases.

  Within one menstrual cycle (~3-4 weeks).

• Change in Stance and Swing Phase Percentages

  Within-subject change in stance (%) and swing (%) durations during gait across phases using BTS-G walk.

  Within one menstrual cycle (~3-4 weeks).

• Change in Pelvic Kinematics

  Within-subject change in pelvic tilt (degree), obliquity (degree), and rotation symmetry (degree) indices obtained from BTS-G walk across phases.

  Within one menstrual cycle (~3-4 weeks).

• Change in Sleep Quality

  Within-subject change in Pittsburgh Sleep Quality Index (PSQI) global score across phases. The PSQI is scored between 0 and 21. Higher scores indicate poorer sleep quality.

  Within one menstrual cycle (~3-4 weeks).

Study Arms (1)

Healthy Women with Regular Menstrual Cycles

Women aged 18-35 years with regular menstrual cycles (28 ± 7 days), evaluated prospectively during early follicular, ovulation, and luteal phases.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy women aged 18-35 years with regular menstrual cycles (28 ± 7 days). Participants will be assessed during three phases of their menstrual cycle (early follicular, ovulation, and luteal) to examine changes in gait parameters, pelvic kinematics, and sleep quality.

You may qualify if:

• Female, aged 18-35 years
• Voluntarily agrees to participate and provides informed consent
• Regular menstrual cycle (28 ± 7 days)
• Able to comply with study assessments and procedures

You may not qualify if:

• History of surgery within the past 6 months
• Current or chronic low back pain
• Dysmenorrhea complaints
• Neurological or orthopedic disorders affecting gait or muscle strength
• Presence of spinal deformities
• Rheumatologic disease
• Climacteric or menopausal period
• Any condition that may affect gait, pelvic kinematics, or sleep quality

Sponsors & Collaborators

• Yuksek Ihtisas University: collaborator
• Hacettepe University: lead

Study Sites (1)

Yuksek Ihtisas University

Ankara, Turkey (Türkiye)

RECRUITING

Study Officials

• Aylin Baykal

  Yuksek Ihtisas University

  PRINCIPAL INVESTIGATOR

• Busra Kalkan Balak

  Yuksek Ihtisas University

  STUDY DIRECTOR

• Gungor Beyza Ozvar Senoz

  Yuksek Ihtisas University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gungor Beyza Ozvar Senoz

CONTACT

505 388 86 17; beyzaozvar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: June 1, 2025
• Primary Completion: January 20, 2026
• Study Completion: February 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)